The goal of this study is to find the safest dose of Pixantrone (BBR 2778) that can be given to patients with Acute Myelogenous Leukemia (AML). After the safest dose is found, up to an additional 86 patients will be enrolled. During this part of the study, the safety and effectiveness will be evaluated.

Phase II: To evaluate the activity of pixantrone in this patient population in terms of objective responses

Estimated Enrollment:

119

Study Start Date:

March 2005

Estimated Study Completion Date:

March 2007

Detailed Description:

This is an open label, single center, phase I/II study of pixantrone in patients with refractory AML. Pixantrone will be administered for three consecutive days on days 1, 2 and 3 of each 21-day cycle, for up to two cycles.

The study has 2 parts; phase I and phase II. In the phase I part of the study, the maximum tolerated dose (MTD) for pixantrone as a single agent in patients with refractory AML will be determined. In the phase II part of the study, up to an additional 86 patients will be treated at the MTD to assess disease response.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with morphologically confirmed diagnosis of relapsed AML with French-American-British (FAB) classification other than M3. Relapse should be demonstrated by the presence of greater than 5% leukemic blasts in the bone marrow or reappearance of greater than 5% leukemic blasts in the peripheral blood within 14 days of registration.

Patients in first or second relapse from prior therapy or hematopoietic stem-cell transplant (HSCT)

A period of at least 21 days must have elapsed from the completion of prior chemotherapy (with or without anthracyclines) and investigational agents to the first dose of treatment in this study, and all acute toxicities from prior therapy must have resolved (with the exception of alopecia).

LVEF >/= 50% as measured by MUGA scan or 2-D ECHO within 14 days prior to registration. Either method is acceptable for measuring LVEF; however, the same method must be used throughout treatment and follow-up.

Patients (male or female) of reproductive potential must commit to use adequate contraception (as defined by the investigator) during study treatment and for 6 months after the last day of study drug administration.

Patients must have signed an approved informed consent prior to beginning protocol specific procedures

Exclusion Criteria:

Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2 according to the following calculation index: X/450 + Y/160 < 1 where X is the doxorubicin dose in mg/m2 and Y is the mitoxantrone dose in mg/m2.

Clinical or documented central nervous system (CNS) involvement with AML.

Prior malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years.

Any condition which, in the judgment of the investigator, would place the patient at undue risk, interfere with the results of the study, or make the patient otherwise unsuitable.

Any circumstance at the time of study entry that would preclude completion of the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106600